The Regulatory Framework



Box 3.1 Summary of protected animals and regulated procedures


  • A protected animal is defined as ‘any living vertebrate, other than man, and any living cephalopod’.
  • Animals are protected from defined stages of development: mammals, birds and reptiles from the last third of gestation or incubation, other forms from the point of independent feeding. Embryonic cephalopods are not protected.
  • A regulated procedure is a procedure applied to a protected animal for a qualifying purpose which may have the effect of causing that animal pain, suffering, distress or lasting harm.





Protected animals


The Act provides protection for certain types of animal used in scientific research. These are known as protected animals. A protected animal is defined as any living vertebrate, other than man and any living cephalopod.


Fetal, larval and embryonic forms are protected from certain stages of development. Mammals, birds or reptiles are protected from two-thirds through gestation or incubation. Fish and amphibia are protected from the point at which they become capable of independent feeding. Cephalopods are protected after they have emerged from the embryonic stage, usually at hatching.


Death is defined as the point at which there is permanent cessation of circulation or destruction of the brain.


Regulated procedures


A regulated procedure is one applied to a protected animal for an experimental or other scientific purpose (see qualifying purpose, below) which may cause the animal pain, suffering, distress or lasting harm equivalent to, or higher than, that caused by the introduction of a needle in accordance with good veterinary practice. All three conditions (in italics) must be fulfilled for the procedure to be regulated.


Procedures may also be regulated if they are part of a series or combination of procedures applied to the same animal for a qualifying purpose which together may cause pain, suffering, distress or lasting harm, even if they are innocuous individually, provided the animal is a protected animal throughout, or if in the course of the procedure it reaches the stage of development when it becomes one.


Procedures applied to animals before they become protected will also be regulated if the animal lives beyond the point at which it becomes protected.


Anything which may result in the birth or hatching of a protected animal is also a regulated procedure if it may cause pain suffering distress or lasting harm. This includes techniques which result in the modification of an animal’s genes, such as pronuclear injections. In addition, the breeding of a genetically modified animal is a regulated procedure if the animal is allowed to live beyond the stage when it becomes a protected animal, and it may experience pain, suffering, distress or lasting harm as a result of the genetic modification.


The use of anaesthesia or analgesia is disregarded when making the judgement about whether there may be any harm; hence procedures carried out on anaesthetised or decerebrated animals are still regulated under the Act.


Exemptions


Certain procedures are exempted from regulation under the Act. Ringing, tagging or marking an animal primarily for identification is not regulated, provided it causes no more than momentary or transient pain and no lasting harm. Examples of appropriate methods are ear tagging, tattooing or microchips.


Recognised veterinary, agricultural or husbandry practices are also not regulated under the Act, although these may be covered by other legislation (see Table 3.2, below). Similarly, administering substances as part of a veterinary clinical trial is not regulated under the ASPA.


The humane killing of a protected animal is a regulated procedure only if the animal is killed for an experimental or other scientific purpose, the place where it is killed is licensed under Section 2C of the Act or is a place specified in a project licence, and the method employed is not as described in Schedule 1 to the Act or specified on the relevant 2C licence. Schedule 1 is a list of approved methods of humane killing that do not require licence authority. See Chapter 8 on euthanasia for details.


Licensing of places


Section 5 of the ASPA requires that places specified in a project licence must be licensed under Section 2C, unless it appears necessary to specify a different place, for example if procedures are to be carried out in the wild or on farms. Most often, regulated procedures are therefore performed at licensed scientific procedure establishments. Establishments where particular types of animal are bred or kept for supplying to research establishments, for either in vivo or ex vivo use, must also be licensed under Section 2C. These types of animal are specified in Schedule 2 to the Act (see Table 3.1).


Table 3.1 Animals included in Schedule 2 to the Animals (Scientific Procedures) Act.





























Mouse (Mus musculus)
Rat (Rattus norvegicus)
Guinea pig
Hamster (Syrian, Mesocricetus auratus, and Chinese, Cricetulus griseus)
Rabbit (Oryctolagus cuniculus)
Dog
Cat
Primate
Any bird of the species Coturnix coturnix (quail)
Ferrets
Gerbil (Meriones unguiculatus)
Frogs of the species Xenopus laevis, Xenopus tropicalis, Rana temporaria or Rana pipiens
Zebrafish

Licences under Section 2C are only issued if the Secretary of State at the Home Office is satisfied that the prospective holder and the place itself comply with the requirements of EU Directive 2010/63.


The application for a 2C licence must identify:



1. a person responsible for overseeing the welfare and care of the animals kept (named animal care and welfare officer, NACWO);

2. a veterinary surgeon, or other suitably qualified person, to provide advice on the health and welfare of the animals (named veterinary surgeon, NVS);

3. a person responsible for ensuring that the persons dealing with animals have access to any information they need about the species concerned;






Box 3.2 The system of control

Regulated procedures may only be carried out if:


  • performed by the holder of a personal licence,
  • authorised by a project licence, and
  • the place is specified in the project licence.






4. a person responsible for ensuring that the persons working with animals are adequately educated and trained and are supervised until they have demonstrated competence (Training and Competency Officer, TCO); and

5. a person responsible for ensuring that the conditions of the licence are complied with.

Note that the same person may be nominated for two roles. If it appears to either the person responsible for animal care or the veterinary surgeon that the health or welfare of an animal gives rise to concern, that person must either notify the relevant personal licence holder or take steps to ensure that the animal is cared for or killed if necessary, using a Schedule 1 or other appropriate method. Thus the NVS and NACWO have a responsibility in addition to that of the research personnel to safeguard the welfare of animals used.


Section 3 of the ASPA outlines the system of control (see Box 3.2). It states that ‘no person shall personally apply a regulated procedure to an animal unless:



a. he holds a personal licence qualifying him to apply a regulated procedure of that description to an animal of that description;

b. the procedure is applied as part of a program of work specified in a project licence authorising the application, as part of that program, of a regulated procedure of that description to an animal of that description; and

c. the place where the procedure is carried out is specified in the project licence.’

Thus, three types of licence are required to be in place before a scientific procedure may be carried out on an animal.


The personal licence


The personal licence qualifies the holder personally to apply regulated procedures of specified descriptions to animals of specified descriptions. The species to be used are divided into groups for this purpose, and procedures are assigned a category, depending on the skill level required to conduct the procedure and whether recovery anaesthesia is used (see Box 3.3). Proposed species groups and categories are outlined in Box 3.3. Note that this may be subject to change and it is advised that the Home Office Inspector be consulted for definitive information.


Before applying for a personal licence, the applicant must usually have completed training appropriate to the species to be used and category of procedures to be included in the personal licence application, and provide evidence of this training when submitting the application. The content of such appropriate training courses is outlined in Chapter 1. The training and competency officer at the institution will be responsible for ensuring that the training is undertaken, and subsequent to obtaining a licence that the person is appropriately supervised, and develops competence in the techniques.







Box 3.3 Proposed species groups and categories of techniques for personal licence applications

Species groups


  • Rodents (including mice, rats, guinea pigs, hamsters and gerbils) and rabbits
  • Small carnivores (including dogs, cats and ferrets)
  • Non-human primates (Old World, e.g. macaques, and New World, e.g. marmosets)
  • Farm animals (including pigs, goats, sheep and cattle)
  • Horses
  • Birds
  • Reptiles
  • Amphibians
  • Fish
  • Cephalopods

Categories of procedure


A. Procedures not requiring any anaesthesia

B. Procedures requiring simple anaesthesia for restraint or non-recovery

C. Procedures requiring more complex anaesthesia plus surgery

D. Procedures requiring anaesthesia plus administration of neuromuscular blocking agents





Applications for personal licences are usually endorsed by the training and competency officer nominated in the Section 2C establishment licence, who has knowledge of the education, training, experience and character of the applicant.


Personal licences are only granted to people over the age of 18 with appropriate education and training, who are competent to apply those procedures and to handle and take care of laboratory animals. Personal licences are reviewed by the Secretary of State every 5 years.


A personal licence can be used under any valid project licence, but can only be used in conjunction with a project licence: it does not authorise the performance of any procedures alone. The licence includes details of the groups of animals on which procedures may be carried out, the categories of technique that may be applied and a set of conditions defining the responsibilities of the personal licence holder.


The personal licence holder bears primary responsibility for the health and welfare of animals on which they have carried out scientific procedures. The Guidance on the Operation of the Animals (Scientific Procedures)5 Act 1986 must be read before applying for a licence.


Responsibilities of personal licence holders


Personal licence holders bear primary responsibility for the welfare of animals on which they have performed scientific procedures. They must ensure that they have the necessary authority on personal and project licences, and avoid unauthorised re-use or release of animals. They must label cages or pens appropriately and keep records of the procedures they have carried out, indicate whether they were supervised or not, and whether their supervisor deemed them competent. They must check their animals daily and make suitable arrangements for any period of absence. They must be familiar with the severity limits and the constraints upon adverse effects contained within the project licence, and seek veterinary advice and treatment if required.


The conditions attached to a personal licence further define specific responsibilities of the holder. These conditions require the holder to implement the three Rs as much as possible, minimising the number of animals used and reducing the duration and intensity of suffering caused, while using procedures that are most likely to provide satisfactory results. The procedures must also result in the death of as few protected animals as possible.


Personal licence holders must take precautions to prevent or reduce to the minimum any pain, suffering, distress or discomfort caused, consistent with the purposes of the procedure. If a procedure is seen to be causing severe pain, suffering or distress, steps must be taken to ameliorate these adverse effects, and any unnecessary pain, suffering, distress or lasting harm must be stopped. Death as an end point must be avoided as far as possible, and be replaced by an early and humane end point. No procedures may be applied that may cause the animal severe pain, suffering or distress which is likely to be long-lasting and cannot be ameliorated. If an animal is found to be in severe pain, suffering or distress that is likely to be long lasting and cannot be ameliorated, it must be killed immediately using an appropriate method. This applies regardless of how important the animal is for the experiment. The welfare of the animal comes first.


Anaesthesia (general or local) should always be used, unless:



  • analgesia (or another appropriate method) is used to ensure that the adverse effects caused by the procedure are kept to a minimum;
  • the procedure will not cause severe pain; and
  • the use of anaesthesia would be more traumatic to the animal than the procedure itself or would frustrate the purposes of the procedure.

In any case, analgesics or other pain-relieving methods must be used to ensure that animals do not experience any pain once the anaesthesia wears off.


Competence and supervision


Personal licence holders must achieve and maintain competence in the procedures used. Until technical proficiency and competence are attained, the personal licence holder must be supervised appropriately. The level and extent of necessary supervision and training should be reviewed and agreed periodically. Initially, direct supervision may be required, but as technical competence is gained the level of supervision can be reduced. However, it is important for new researchers to continue to seek guidance even once competence is achieved. Supervision does not lessen the individual responsibility of the personal licensee to comply with the provisions of the Act and the terms and conditions of the licence.


Delegation of authorities


A personal licence holder may request authority from the Secretary of State to use unlicensed assistants to perform certain techniques specified on their personal licences that require no technical skill or knowledge, such as the filling of food hoppers and water bottles with previously altered diets or liquids, or pairing/grouping associated with the breeding of animals. The personal licence holder remains responsible for the welfare of the animals involved.


The competence of the personal licence holder is a key factor in maintaining the welfare of laboratory animals. Personal licence holders should take responsibility for ensuring that they are fully trained and competent before performing regulated procedures, and for seeking advice and assistance when necessary.


Project licences


A project licence sets out a programme of work, and authorises the application, as part of that programme, of specified regulated procedures to animals of specified descriptions at specified places. A ‘programme of work’ is considered to be the combination of regulated procedures and end points to be applied to protected animals to achieve the scientific objectives specified in the project licence. Section 5 of the ASPA sets out the requirements of the Act for project licences.


The project licence details the background to and the likely benefits from the specific work to be carried out and the likely harm to be caused to the animals. The plan of work indicates how the purposes are to be achieved, linking the performance of specified regulated procedures to the achievement of the purposes. Protocol sheets describe the procedures to be performed on individual animals, including details of the likely adverse effects of the procedures, and what steps will be taken to minimise these, including the use of analgesics and humane end points. A severity classification is stated for each individual protocol: these may be mild, moderate, severe or unclassified, which is used if the procedure is conducted entirely under terminal anaesthesia. The severity categories are not discrete entities but form a spectrum across a wide range of adverse effects. It is necessary to consider not only the immediate effects on the animal, but the longer-term effects as well, to gauge the overall effects of the procedure. Also, if corrective action is taken to prevent suffering at an early stage, the severity level may be kept down. Thus, the Act requires that the likely benefits are maximised, while harm caused to the animals is minimised.


Project licences are issued to someone who can take overall responsibility for the work. The holder should have expertise in the particular area of science, and will generally need to be proficient in the regulated procedures to be performed. They should also be able to design and manage experiments (including expertise in statistics where appropriate), supervise and guide personal licensees, and implement the three Rs of Reduction, Refinement and Replacement as much as possible. Therefore they must been trained in a relevant scientific discipline, demonstrate that they have specific knowledge relating to the species of animal to be used and have received training in designing programmes of work.


Assessment of projects and severity classification


Project licence applications are assessed before granting, to ensure that:



  • the programme of work is justified from a scientific or educational point of view or is required by law;
  • the purposes of the programme of work justify the use of protected animals; and
  • the regulated procedures will be applied in the most humane and environmentally sensitive manner possible

The Secretary of State will evaluate the objectives of the programme of work and its predicted scientific benefits or educational value, and assess the compliance of the programme of work with the principles of Replacement, Reduction and Refinement. He will also assess the likely severity of the procedures to be used and assign them a severity category, be it non-recovery, mild, moderate or severe. A harm/benefit analysis will then be carried out to assess whether the harm that may be caused is justified by the expected benefit to man, animals or the environment. The Secretary of State will also determine whether the programme should be assessed retrospectively. This will usually be the case if the project involves non-human primates or severe procedures. A retrospective assessment will assess whether the programme of work has been carried out, whether the objectives were achieved and the amount of harm actually caused to the animals. It will also determine whether any lessons can be learnt from the programme of work that may contribute to the further implementation of the three Rs.


Qualifying purposes


The ASPA restricts the purposes for which licences may be issued. These are known as qualifying purposes, and are:



  • basic research;
  • translational or applied research with one of the following aims:

    • the avoidance, prevention, diagnosis or treatment of disease, ill health or other abnormality, or their effects in man, animals or plants,
    • the assessment, detection, regulation or modification of physiological conditions in man, animals or plants, or
    • the improvement of the welfare of animals or of the production conditions for animals reared for agricultural purposes;

  • the development, manufacture or testing of the quality, effectiveness and safety of drugs and foodstuffs;
  • the protection of the natural environment in the interests of the health or welfare of man or animals;
  • research aimed at preserving the particular species of animal;
  • higher education or training for the acquisition, maintenance or improvement of vocational skills;
  • forensic inquiries.

Project licences may not be granted for programmes of work which fall outside these categories. Project licences are valid for a maximum of 5 years, after which time a new application must be made if the programme of work is to continue. Non-technical summaries must be submitted with a project licence application, for publication.


Project licence conditions


Project licences are subject to a number of conditions. Like personal licence conditions, they require that the principles of Replacement, Reduction and Refinement are complied with. The procedures must use the minimum number of animals with the lowest capacity to experience pain, suffering, distress or lasting harm; cause the least pain, suffering, distress or lasting harm; and be most likely to provide satisfactory results. Procedures must not be applied if the procedure may cause severe pain, suffering or distress that is likely to be long-lasting and cannot be ameliorated. Procedures must result in the death of as few protected animals as possible; and the duration and intensity of suffering caused to those animals that die must be minimised. In any case, once the purpose of the procedure has been achieved, the procedure must be stopped and appropriate action taken to minimise the suffering of the animal. A decision must be taken by a veterinary surgeon or other competent person at the end of the procedures as to whether the animal should be kept alive or killed. If it is suffering or likely to suffer adverse effects from the procedure, the animal must be killed.


Additional conditions must be met before a project licence authorising the use of endangered animals, primates, cats, dogs or equidae will be granted, and no project licence will be granted authorising the use of great apes. Animals taken from the wild and endangered species are also afforded additional protection.


The project licence holder (also known as the PPLh) must ensure that personal licence holders working on the project are supervised until they have demonstrated the requisite competence.


To enable a project licence holder to manage a project efficiently everyone involved must be fully aware of the contents of a project licence and of their responsibilities. It is particularly important that everyone involved has access to an up-to-date copy of the licence.


Fate of animals at the end of procedures


The ASPA requires that once a series of regulated procedures is finished, the personal licence holder must ensure that the animals are killed if they are suffering or likely to suffer adverse effects. If a veterinary surgeon determines that they are not suffering or likely to suffer, then they may remain alive at the licensed establishment. Animals can then be set free or rehomed – for example to a farm or to be kept as pets – if certain conditions are met. Permission is required from the Secretary of State, the animal must be fit to be released, it must pose no danger if released, and measures must be taken to safeguard its well-being. For wild animals there are additional conditions. The fate of the animals should be specified on the project licence.


The Section 2C licence


The holder of this licence has overall legal responsibility for all the animal facilities and for all the procedures carried out in an institute. They have a number of responsibilities, including the following.



  • They must ensure that Replacement, Reduction and Refinement are implemented fully.
  • A register of people must be maintained who are competent to kill protected animals, listing methods the person has been deemed competent to apply and on which species. People on the register must be trained and supervised until competent. There must be sufficient people trained so that someone is available at all times if an animal needs to be killed in an emergency.
  • The installations and equipment at the establishment must be maintained such that they are appropriate for the species held and the procedures performed. This must permit reliable results to be obtained while using the minimum number of animals in procedures of minimum severity.
  • The facilities must be maintained in accordance with the requirements of Annex 3 of EU Directive 2010/634. The fabric of the buildings in which experimental or breeding animals are kept must be maintained to a satisfactory standard, and the accommodation must provide adequately for the animals’ needs, including quarantine and acclimatisation. The Home Office has issued a Code of Practice, based on the requirements in the previous EU Directive, in which the optimum environmental conditions and minimum cage sizes for protected animals were laid down6. This will be updated with the new requirements, which establishments will have to meet by 2017.
  • They must ensure that sufficient staff are available to care for the protected animals kept. The staff must be adequately educated and trained, and supervised until they are competent.
  • They must ensure that the physical environment and the well-being and state of health of animals are checked at least daily by a competent person, so that problems may be rapidly identified. All animals must be provided at all times with adequate care and accommodation appropriate to their type or species, and any restrictions on the extent to which the animal can satisfy its physiological and ethological needs must be kept to the absolute minimum.
  • They must maintain an Animal Welfare and Ethical Review Body. This comprises as a minimum the person responsible for day-to-day care of animals and the veterinary surgeon. At an establishment where regulated procedures take place there must also be a scientist. This body provides advice on animal welfare; for example acquisition, accommodation, care and use of animals, the three Rs and advances in techniques. It may review internal processes and projects, including making assessments of adverse effects and implementation of the three Rs. The Animal Welfare and Ethical Review Body must keep records of advice given and decisions made.
  • Records must be kept of the number and the species of animals bred, acquired, supplied, used in procedures, set free or re-homed.
  • They must prevent unauthorised procedures. The Section 2C licence holder must ensure that all procedures carried out in the establishment are properly authorised, and must put in place systems of management that ensure compliance with the requirements of the Act and the terms and conditions of the licences.
  • Identification of animals: dogs, cats and primates kept at the establishment must be individually and permanently identified and have an individual history file, which stays with the animal if it is moved. Equidae, farm animals and adult birds should also be identified. Each cage or pen should be properly labelled with the identity of the animals within.

Other responsibilities that the Section 2C licence holder is required to discharge include ensuring that health records are maintained under the supervision of a veterinary surgeon for animals held at the establishment, and ensuring that animals kept alive at the completion of regulated procedures are kept under the supervision of a veterinary surgeon unless moved, rehomed or re-used.


The named animal care and welfare officer


The Section 2C licence names a person responsible for the day-to-day care of the protected animals kept there (the named animal care and welfare officer or NACWO). This person has responsibilities laid down in the Act (statutory responsibilities), and other additional responsibilities. Their statutory responsibilities require that the NACWO should notify the relevant personal licence holder or arrange for the care or destruction of an animal if the health or welfare of that animal gives rise to concern. They may also notify the veterinary surgeon in such circumstances. The NACWO’s responsibilities include both stock and experimental animals.


The NACWO is usually a senior animal technician, with expert knowledge and experience of animal technology. They ensure that husbandry and care of animals are carried out to the standards described in the relevant Codes of Practice. They will be familiar with Schedule 1 and other appropriate methods of killing. The NACWO will usually ensure that all the animals are checked daily by a competent person and that the environmental conditions are recorded. The NACWO should be familiar with the project licences in use and be involved in the local animal welfare and ethical review body. The NACWO and animal technicians will often be proficient in the techniques to be used and will be a valuable source of advice.


The named veterinary surgeon


The Section 2C licence also names a veterinary surgeon to advise on the health and welfare of the animals (the named veterinary surgeon). The veterinary surgeon also has statutory responsibilities under the Act, and other additional responsibilities required by the Royal College of Veterinary Surgeons and Home Office. Named veterinary surgeons must undertake specific training, and there is an ongoing requirement for continuing professional development.


The statutory responsibilities require that the vet should provide advice on the health and welfare of the animals, and notify the relevant personal licence holder or arrange for the care or destruction of an animal if the health or welfare of that animal gives rise to concern.


In addition, the vet will visit all parts of the establishment frequently enough to be able to monitor the health and welfare of animals kept at the establishment. They are responsible for the diagnosis and treatment of diseases in the protected animals, and for directing the use of controlled and prescription-only medicines in the animals. They can advise on health screening and husbandry requirements, and will maintain health records. They will also be familiar with Schedule 1 methods of humane killing. The vet should be familiar with the project licences in use, and be able to provide advice to licensees regarding refinement of techniques, non-animal alternatives and selection of animal models. The vet may also perform techniques, training of licensees and the drafting of new applications and amendments. They should take an active role in the Animal Welfare and Ethical Review Body. Appropriate veterinary cover will be available at all times. The vet is a valuable source of advice and assistance, and personal licence holders are encouraged to seek advice from the vet and the NACWO on a regular basis.


Additional controls


Re-use


Section 14 describes the regulations relating to the re-use of animals, limiting the cumulative severity which any individual animal might experience. Once a series of regulated procedures for a particular purpose has been concluded, no animal may be re-used unless authorised by the Secretary of State. Animals may be re-used only if the actual severity of no more than one of the preceding procedures was classified as severe, and a veterinary surgeon with knowledge of the lifetime experience of the animal has advised that the animal’s general state of health and well-being has been fully restored. The likely severity of the further procedure to be applied must be classified as non-recovery, mild or moderate. If the animal has experienced severe adverse effects, re-use will only be permitted where there is particularly strong justification.


Neuromuscular blocking agents


Neuromuscular blocking agents prevent an animal from moving, but do not diminish pain sensation. If used without appropriate analgesia or anaesthesia, there is the potential for pain and distress to go undetected. The use of these agents must be expressly authorised by the personal licence and the project licence, and they must be used in combination with an appropriate level of anaesthesia or analgesia. In addition, the Secretary of State must be satisfied that the purposes of the programme of work cannot be achieved without their use.


Schedule 1


Schedule 1 to the Act describes methods of humane killing. Killing a protected animal using one of the methods described in Schedule 1 is not considered to be a regulated procedure, and no project or personal licence authorities are required. However, personnel who carry out killing by a Schedule 1 method must be competent to do so, and listed in a register maintained by the Section 2C licence holder. Using a method not listed on Schedule 1, or a Schedule 1 method on an animal for which it is not deemed appropriate, constitutes a regulated procedure, and must be licensed by both project and personal licences. Sometimes, an alternative method may be specified on the relevant 2C licence, for which no additional licence authority is required. Further information on methods of humane killing can be found in Chapter 8.


Administration of the Act


Assessment of licences and inspection of premises


The Act is administered by the Secretary of State at the Home Office, who takes advice from a number of sources as to whether and on what terms to grant a licence under the Act. The main source of advice is a network of Home Office Inspectors, who visit research establishments and study all applications for licences to work on animals to ensure the work is justified and meets the criteria laid down in the Act. Inspectors also visit establishments and conduct periodic reviews of licences to assess compliance with their terms and conditions. Any non-compliance is reported to the Secretary of State, who may issue compliance notices, revoke licences, impose retraining requirements or formally admonish the licence holder. If an inspector believes that an animal is suffering excessively they may require it to be killed immediately.


The Home Secretary may also take advice from an independent assessor, and regarding project licence applications from the Committee for the Protection of Animals Used for Scientific Purposes. This is a panel of senior researchers, legal, veterinary and medical personnel and representatives of welfare groups. The Committee provides advice on matters such as the acquisition, breeding, accommodation, care and use of protected animals to both the Secretary of State and the local Animal Welfare and Ethical Review Bodies. The committee aims to ensure that best practice is shared, and may also promote the sharing of such practices with other EU member states.


Offences and infringements


Breaches of certain sections of the Act or licence conditions may be offences under the Act, and may potentially lead to a prison sentence or a fine. Other breaches may not be offences but may be classed as infringements, and may result in variation or revocation of the licence.


The Secretary of State can issue a compliance notice, if a licence holder has failed or is failing to comply with the Act or licence conditions. He may also suspend licences if it appears to be urgently necessary for the welfare of any animal. If a Section 2C licence is suspended, animals may no longer be bred or kept there, and no further regulated procedures may be performed. Any animal that is suffering or likely to suffer as a result of regulated procedures may have to be humanely killed.


If a project licence is suspended, all regulated procedures being carried out under the authority of that licence must immediately stop.


If a personal licence is suspended, the holder may not perform regulated procedures. The responsibility for the care of the animals that have been used by that licensee must be transferred immediately to another personal licence holder with the necessary authorities.


Communication


Within a designated establishment many people are involved in caring for and maintaining the welfare of protected animals. The Act describes several persons with particular responsibilities towards animals, including the 2C licence holder, project licence holder, personal licence holder, veterinary surgeon, training officer and animal care and welfare officer. Open communication between these people is vital if everyone is to carry out their responsibilities effectively and if animal welfare is to be maintained. The animals cannot speak for themselves: they rely on personnel to attend to their needs.


Statistics of Animal Usage


The statistics from the annual returns submitted by project licence holders show that on 31 December 2011 there were 181 scientific procedure establishments in the UK, with 2624 project licences and 15 403 personal licensees covering the work that was done7. In 2011 3.71 million animals, of which 71% were mice and 15% were fish, were used in 3.79 million procedures. Birds were used in 4% of procedure, the majority of these being domestic chickens. Dogs, cats and primates together accounted for fewer than 7300 animals, less than 0.25% of the animals used. Genetically altered animals accounted for 54% of procedures.


Fundamental or applied studies into medical, veterinary or biological research, development and production accounted for 89% of procedures, and the remaining animals were used in toxicology.


These figures should be considered in the light of other forms of animal usage. For example, approximately 900 million poultry and 40 million cattle, calves, pigs and sheep are slaughtered for food each year in the UK8. The number of animals in research is therefore small in comparison, but nevertheless it raises ethical issues and must be conducted to the highest possible standards.


Other Relevant Legislation


There are many other pieces of legislation, regulations and guidelines which may be relevant to certain areas of laboratory animal use. The ASPA allows personal licence holders to conduct activities that would otherwise be prohibited under other legislation, protecting licence holders from prosecution. However, this protection is only effective if operating in compliance with the three licences of the ASPA. In addition, compliance with some of these pieces of other legislation (e.g. Wildlife and Countryside Act 1981) is still required for some types of work. Licence holders are required to ensure that they are in compliance with all relevant legislation. Many of these are summarised in Table 3.2. The list is not exhaustive.


Table 3.2 Legislation relevant to animal use in the UK.










































Protection of animals
Animal Welfare Act 2006
This places a duty of care on an owner not to be cruel to an animal and to ensure its welfare needs are met, and includes acts of omission. It applies to ‘animals that are commonly domesticated in the UK, or that are under the control of man’, which includes laboratory animals. This Act applies to stock and experimental animals held at establishments.
Wildlife and Countryside Act 1981
This Act provides protection for wild animals and plants, and makes it an offence to kill, injure, trade in or take a listed species from the wild, to possess a scheduled species or to damage, destroy or obstruct access to their habitat. Working with certain wild animals requires licensing under this Act as well as under the ASPA. Licences under this Act are issued by different bodies in different countries of the UK, for example English Nature, Scottish Natural Heritage or the Countryside Council for Wales.
Veterinary Surgeons Act 1966
This requires that only a registered veterinary surgeon may carry out acts of veterinary surgery. This includes diagnosis and treatment of disease in animals.
The Animal Health Act 1981
This Act is concerned with animal disease control, such as rabies, bovine tuberculosis, bovine spongiform encephalopathy, bluetongue, swine fever, and foot and mouth. This places controls on imports and movements of various species. Many Orders under this Act impact on the use of animals in research, for example as follows.

  • Transport of animals is covered by the Welfare of Animals (Transport) Order 2007. This requires that animals must not be transported in a way that is likely to cause injury or undue suffering to them.
  • Import of live animals and products of animal origin is covered by several orders. UK import health requirements for live animals and products of animal origin are determined by DEFRA. Rabies quarantine is required for some animal species (e.g. primates).
  • Regulations for export of live animals and tissues may require that a veterinary check is performed to certify health of animals and fitness to travel. Exact import requirements vary widely between countries.
  • The Pigs (Records, Identification and Movement) Order 2011. This and other orders place restrictions on the movement of farm animal species, in order to limit the spread of animal diseases.
Licensees are advised to check exact requirements for animal movement, import or export with DEFRA. Note: Home Office permission may be required to export any animal on a regulated procedure (this includes all genetically altered animals), and for acquisition of Schedule 2 animals from abroad.
Convention on International Trade in Endangered Species (CITES)
CITES is an international agreement between governments. Its aim is to ensure that international trade in specimens of wild animals and plants does not threaten their survival.
Protection of humans
Health and Safety at Work Act 1974
This Act requires that employers ensure the health and safety of workers, visitors and contractors in the workplace. Relevant regulations include the following.

  • Control of Substances Hazardous to Health (COSHH) Regulations 2002. These require risk assessments to be done and protective measures put in place. ‘Substances’ include animal allergens and pathogens.
  • Genetically Modified Organisms (Contained Use) Regulations 2005. These require that all activities involving GMOs must be assessed for risk to humans and the environment. The HSE must be notified of all premises using GMOs before first use. Activities are classified according to risk, Class 1 (low) to Class 4 (high), and HSE must be notified of individual activities of Class 2 to Class 4.
  • Ionising Radiation Regulations 1999. This includes X-rays, computed tomography (CT) scans, dual x-ray absorptiometry (DXA) scans, radiotherapy, radionucleotide imaging and administration of a radioactive substance. Employers are legally required to ensure compliance with health and safety regulations on radiation. Note: magnetic resonance imaging and ultrasound do not involve ionising radiation.
  • Reporting of Injuries Diseases and Dangerous Occurrences (RIDDOR). These require that certain workplace injuries and conditions, including laboratory animal allergies, are reported to the HSE.
The Veterinary Medicines Regulations 2011
These control the manufacture, distribution and marketing of veterinary medicines. This defines prescription-only medicines (or POM-Vs), which may only be given to animals under the direction of a veterinary surgeon. These regulations are updated every year.
The Misuse of Drugs Act 1971 and Misuse of Drugs Regulations 2001
This controls the use of ‘dangerous or otherwise harmful’ drugs (controlled drugs), such as those which may be addictive or drugs of abuse. Drugs controlled under this Act may be classified into one of five schedules. Schedule 1 includes many drugs of abuse which are generally not used as medicines. Schedule 2 includes potent drugs such as morphine, pethidine and fentanyl. These drugs have strict requirements for storage and record keeping. Drugs in Schedules 3–5 have less strict storage and recording requirements.
DEFRA, Department for Environment, Food and Rural Affairs; GMO, genetically modified organism; HSE, Health and Safety Executive.

Legislation falls generally into two categories: laws for the protection of animals (usually administered by the Department for Environment, Food and Rural Affairs), and laws for the protection of humans (administered by the Department of Health or the Health and Safety Executive).


References


1. Harvey W (1628). Exercitatio Anatomica de Motu Cordis et Sanguinis in Animalibus [On The Motion Of The Heart And Blood In Animals]. London. Translated by R Willis. In: Internet Modern History Sourcebook, www.fordham.edu/halsall/mod/modsbook.html


2. Russell WMS and Birch RL (1959; republished 1992). The Principles of Humane Experimental Technique, special edition. Wheathampstead: Universities Federation for Animal Welfare


3. Council of Europe (1986). European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes. Strasbourg: Council of Europe. conventions.coe.int/Treaty/en/Treaties/HTML/123.htm


4. Council of the European Union (2010). Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes. Official Journal of the European Union 276/33–276/79


5. HMSO (2000). Guidance on the Operation of the Animals (Scientific Procedures) Act 1986. London: The Stationery Office. www.archive.official-documents.co.uk/document/hoc/321/321.htm.


6. Home Office (1989). Code of Practice for the Housing and Care of Animals Used in Scientific Procedures. London: The Stationery Office. www.official-documents.gov.uk/document/hc8889/hc01/0107/0107.pdf


7. Home Office (2011). Statistics of Scientific Procedures on Living Animals Great Britain 2011. London: The Stationery Office


8. Royal Society for the Prevention of Cruelty to Animals (2012). Animal Slaughter Factfile. www.rspca.org.uk/allaboutanimals/farm/slaughter/factfile


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Jul 30, 2017 | Posted by in GENERAL | Comments Off on The Regulatory Framework
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